We work with you to establish the most effective filtration solution for your process based on your goals and desired process improvements including: • Minimizing product loss • Reducing downtime • Increased yields • Reduce over processing • Guarantee sterility • Minimizing risk to your process • Extending service time • Promoting best practice Once the correct Parker filters have been chosen, we work closely with you to qualify the use of our products within your process. Development of an application specific strategy Our Technical Support team use your identified parameters to determine the qualification package required. This demonstrates that our filters are capable of meeting the performance goals required of your process. We follow the specific requirements of the current revision of ISO134081 and guidance from PDA Technical Report No. 262 to validate the sterile filtration step in your process. Test work is carried out by our experienced team of Scientists and Engineers in our dedicated test facilities. Meeting the standards Global investment programmes have created first class R&D, manufacturing and support facilities across the world. We are committed to industry standards including current versions of: • ISO 9001 - Quality Management Systems • ISO 13485 - Quality Management Standards for medical devices • ISO 14001 - Environmental Management 1 ISO13408-2 Aseptic Processing of Healthcare Products - Part 2: Sterilizing Filtration 2 PDA Technical Report No. 26: Sterilizing Filtration of Liquids Remove the barriers to successful validation Supported by state-of-the-art technical facilities and a specialized international team of dedicated Engineers and Scientists, Parker is committed to supporting your validation process. parker.com/bioscience
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